Ingeniero de Procesos Biofarmacéuticos Sr.

Placements24; Tijuana; Presencial; MXN 900.000 - 1.100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Health benefits

On-site role in Tijuana

Professional growth opportunities

Descripción de la vacante

Placements24 is seeking an experienced Ingeniero de Procesos Biofarmacéuticos Sr. to join their manufacturing operations in Tijuana, MX.

The role focuses on development, optimization, and scale-up of biopharmaceutical processes, covering upstream cell culture and downstream purification. You will collaborate with R&D, QC, QA, and Manufacturing to ensure GMP-compliant production, process validation, and robust process transfer to scale.

Formación

• Minimum 6 years in biopharmaceutical process development or manufacturing.
• Strong knowledge of GMP and regulatory requirements.
• Experience with mammalian cell culture upstream and purification downstream.
• Excellent problem-solving and project management skills.
• Willingness to work on-site in Tijuana, MX.

Responsabilidades

• Lead process development and optimization for upstream and downstream biopharmaceutical manufacturing.
• Scale-up processes from laboratory to pilot and commercial scales.
• Develop and execute process validation strategies and protocols.
• Troubleshoot and resolve complex process-related issues encountered during manufacturing.
• Identify opportunities for process improvement to enhance yield, efficiency and reduce costs.
• Ensure all process development and manufacturing activities comply with GMP and regulatory requirements.
• Author technical reports, process descriptions, and documentation for regulatory submissions.
• Collaborate with cross-functional teams, including R&D, QC, QA, and Manufacturing.
• Stay abreast of new technologies and methodologies in biopharmaceutical process development.

Conocimientos

Bioprocess development

Mammalian cell culture

Protein purification

Process scale-up

GMP compliance

Regulatory knowledge

Educación

Bachelor's degree in Chemical Engineering

Master's degree in Bioengineering or related field

Herramientas

Process modeling tools

Descripción del empleo

About the Role

Our client, a rapidly growing biopharmaceutical company, is seeking a highly experienced Ingeniero de Procesos Biofarmacéuticos Sr. to join their manufacturing operations in Tijuana, Baja California, MX . This role is crucial for the development, optimization, and scale-up of biopharmaceutical manufacturing processes, including upstream (cell culture) and downstream (purification) operations. The ideal candidate will possess a deep understanding of bioreactor technology, cell culture optimization, protein purification techniques, and process validation. You will work closely with manufacturing, quality control, and R&D teams to ensure the efficient and compliant production of high-quality biological products. Your expertise will be vital in ensuring process robustness, yield improvement, and regulatory adherence. We are looking for a hands-on engineer with a strong track record in bioprocess development and manufacturing.

Key Responsibilities

• Lead process development and optimization efforts for upstream and downstream biopharmaceutical manufacturing.
• Scale-up manufacturing processes from laboratory to pilot and commercial scales.
• Develop and execute process validation strategies and protocols.
• Troubleshoot and resolve complex process-related issues encountered during manufacturing.
• Identify opportunities for process improvement to enhance yield, efficiency, and reduce costs.
• Ensure all process development and manufacturing activities comply with GMP and regulatory requirements.
• Author technical reports, process descriptions, and documentation for regulatory submissions.
• Collaborate with cross-functional teams, including R&D, QC, QA, and Manufacturing.
• Stay abreast of new technologies and methodologies in biopharmaceutical process development.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Bioengineering, Biotechnology, or a related field.
• Minimum of 6 years of experience in biopharmaceutical process development and/or manufacturing.
• Strong experience with mammalian cell culture (upstream) and protein purification (downstream) processes.
• Proficiency in process scale-up, technology transfer, and process validation.
• In-depth knowledge of GMP regulations and their application in biopharmaceutical manufacturing.
• Experience with process modeling and simulation tools is a plus.
• Excellent analytical, problem-solving, and project management skills.
• Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
• Must be willing to work on-site in Tijuana, Baja California, MX.

Benefits

• Our client offers a competitive salary, comprehensive health benefits, and opportunities for professional growth within a dynamic and expanding company.
• This on-site role provides the chance to work with cutting-edge biopharmaceutical manufacturing technology in the thriving region of Tijuana, Baja California, MX.
• You will contribute to the production of vital therapies and have a direct impact on patient well-being.
• We offer a collaborative work environment and ongoing training.
• Paid time off and performance bonuses are part of the compensation package.
• Join a team dedicated to advancing biopharmaceutical manufacturing.